基于真实世界对华法林、达比加群酯、利伐沙班上市后不良事件信号的挖掘和分析  

Real-world based mining and analysis of post-marketing adverse event signals for warfarin,dabigatran,and rivaroxaban

作　　者：刘园园 杨洋 郭雪婷 韩畅 刘军 LIU Yuanyuan;YANG Yang;GUO Xueting(Department of Pharmacy,The Seventh Affiliated Hospital of Xinjiang Medical University,Urumqi 830028,China)

机构地区：[1]新疆医科大学第七附属医院药学部,乌鲁木齐830028

出　　处：《中国处方药》2025年第1期1-5,共5页Journal of China Prescription Drug

基　　金：自治区卫生健康青年医学科技人才专项科研项目(WJWY-202462)。

摘　　要：目的挖掘华法林、达比加群酯、利伐沙班的药品不良事件(ADE)信号,为口服抗凝药物临床安全合理应用提供参考。方法基于美国FDA不良事件报告系统(FAERS),采用报告比值比法、比例报告比法对FAERS项目中目标药物在FDA获批上市起至2023年第1季度上报的ADE报告进行数据挖掘,分析报告病例基本情况;映射得到对应的系统器官分类(SOC)以及首选术语(PT)并进行分析。结果共收集到以目标药物为首要怀疑药物的ADE报告223649例,74.29%的报告集中在65岁以上人群。从中挖掘得到有效信号1678个,涉及27个SOC,发生频次最高的为胃肠道系统疾病。PT分析发现:根据频次排序,华法林、达比加群酯和利伐沙班居于首位的PT均为胃肠出血;根据信号强度排序,华法林中居于首位的PT为胃出血(1030例),达比加群酯为下消化道出血(1162例),利伐沙班为肠憩室出血(784例)。结论本研究的结果对真实世界中华法林、达比加群酯、利伐沙班的应用提出了重要警示,在临床实践应用中,高龄老年患者应用新型口服抗凝药物(NOACs)时,消化道出血风险应引起重视,应充分评估出血风险,重视个体化给药,严密动态监测出血迹象。Objective To excavate the adverse drug even(t ADE)signals of warfarin,dabigatran etexilate,and rivaroxaban,and provide reference for its clincal rational use.Methods Based on the FDA Adverse Event Reporting System(FAERS),data mining was performed on the ADE reports of the target drugs in the FAERS program reported from the FDA approval until the first quarter of 2023.The basic profile of the reported cases was analyzed using the reported ratio ratio method and the proportional reporting ratio method,and the mapping was analyzed to obtain the corresponding system organ classification(SOC)and preferred term(PT).Results A total of 223649 ADE reports with the target drug as the first suspected drug were collected,and 74.29%of the reports were concentrated in people over 65 years old.From this mining,1678 effective signals were obtained,involving 27 SOC,and the most frequent cases were gastrointestinal system diseases.Preferred term(PT)frequency ranking revealed that the highest PT of warfarin,dabigatran etexilate and rivaroxaban were gastrointestinal bleeding;according to signal intensity,the highest PT for warfarin was gastric bleeding(1030 cases),for dabigatran etexilate it was lower gastrointestinal bleeding(1162 cases),and for rivaroxaban it was intestinal diverticulum bleeding(784 cases).Conclusion The results of this study provide an important warning about the application of warfarin,dabigatran etexilate,and rivaroxaban in the real world.The clinical use of novel oral anticoagulants(NOACs)in elderly patients should focus on the risk of gastrointestinal bleeding,assessment of the patient's bleeding risk,individualized patient dosing,and dynamic monitoring of the patient's signs of bleeding.

关 键 词：口服抗凝药物 药品不良事件 FAERS 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]